From:Packaging Europe News

A recent report from a leading U.S. global market research and consultancy company "MarketsandMarkets" has predicted that the worldwide pharmaceutical packaging market will be worth $78.79 billion by 2018. Packaging is an integral component supporting the pharmaceuticals market, providing advanced solutions to assist correct dosing, accurate dispensing and compliance with prescription. The functionality of pharmaceutical and medical packaging is crucial in providing user-friendly packaging for both the ageing population whilst ensuring child-resistant properties, and ever-tightening and stringent regulations applied to the market drive innovations in the areas of anti-counterfeiting and tamper-proof packaging. Together, these factors initiate ongoing developments in technology and innovations for the demanding market, as Libby White reports.

"Questions pharmaceutical companies have to ask themselves before selecting packaging are becoming more complex," comments Sascha Karhoefer, director, Global Injectable Container Solutions, West Pharmaceutical Services, Inc. "Today´s packaging selection is not only about closing a container, but also about considering the sensitivity of many drugs and the safety requirements needed to maintain efficacy during the drug product's lifecycle.  Selecting the right packaging components has a direct impact on operational efficiency, drug stability, drug safety and patient protection."

Balancing child-resistance and senior-friendliness

The demand for child resistant packaging forms is understandably enormous, due to its significance in saving lives and preventing accidents. According to the European Child Safety Alliance, three thousand children aged under 14 die every year in Europe from acute poisoning. Ninety per cent of these accidents occur in the home.

An award winning example of packaging that addresses this issue is "Locked4Kids", the first reclosable, child resistant carton box for packaging pharmaceuticals. Ecobliss, the manufacturer and holder of the patent, trusts in a special Romaco Promatic cartoning solution for the production process. This patented system is winner of the "Zilveren Noot 2014", the renowned Dutch packaging award and winner of the best innovation in the packaging category of the CPhi Awards.

Locked4Kids cartons contain special blister trays with small hooks on the long sides. These hooks are placed diagonally to one another, so that the tray is locked securely when it is pushed right in. In order to remove the tray, both hooks have to be released simultaneously by pressing on the box firmly and evenly at the marked points with the thumb and forefinger. This is no problem for adults but impossible for children, whose hands are too small to span the width of the carton and push both hooks in at once. Furthermore, both sides of the box are coated with a tear resistant laminate to prevent children from simply ripping it apart.

The Locked4Kids concept developed by Ecobliss Holding B.V., is ideal as child resistant packaging for a broad array of pharmaceutical, chemical and toxic products in solid, powder or liquid form. "We were on the lookout for a reliable partner to assist with the technical implementation of Locked4Kids and found an experienced, innovative and flexible provider of packaging solutions in Romaco Promatic," says Ron Linssen, founder and managing director of Ecobliss Holding B.V. "Thanks to Romaco Promatic's proven cartoning solutions, we were able to bring the Locked4Kids concept to the market in minimal time."

Another example of packaging introduced this year that finds the optimum balance between child-resistance and senior-friendly packaging is the Dosepak®Express with Optilock technology from MWV. Optilock MWV technology is an exclusive lock mechanism. Integrated with Dosepak Express, it offers a smaller package (23 per cent less than the original Dosepak Express), which can contain the same number and the same size of drugs.

The packaging features a customizable calendar blister allowing patients to easily track their medications, flat spaces to provide readable drug information and links to connect to other compliance support programs. Dosepak Express with Optilock technology can be manufactured on existing equipment through a quick process change. This solution provides a child safety system but is also easy to open for the elderly.

Correct dosing and compliance

To deliver correct dosing whilst also providing ease-of-use for patients is a major trend for pharmaceutical packaging. Auto-injectors are key solutions that can ensure ease of use and compliance with patient adherence to treatment. For example, Pro-Ject™ from Aptar Pharma is a disposable auto-injector built around a standard prefilled glass syringe. It also features innovative visual signals and sounds to indicate needle insertion and removal.

Furthermore, a collaboration between Sanofi and Haselmeier has created JuniorSTAR, an injection pen that facilitates self-injection of insulin for diabetic children. It is capable of delivering from 1 to 30 units per injection, is particularly light and easy to transport (about 34g). Accurate and robust, this injection pen conforms to the new ISO 11608-1: 2002 regulations, and is available in three different colours: blue, red and silver.

Dedicated to the development of drug delivery solutions. West Pharmaceutical Services, Inc.'s most recent innovation is the Daikyo Crystal Zenith® prefilled syringe system. Daikyo Crystal Zenith (CZ), a cyclic olefin polymer, possesses many advantageous properties, including glass-like transparency, which permits visual inspection of the manufactured components and of the paren-teral products that are delivered to the end user. The CZ material's tight dimensional tolerance and consistency of syringe functionality can help to make an auto-injector's operation predictable - which makes it an easy-to-use, safe option for the patient. Amongst its latest innovations on offer are also the SmartDose® electronic wearable injector, the ConfiDose®auto-injector and the SelfDose® injector.

Developments have also been made in the field of dispensing pellets, micro-tablets and capsules. For example a system from Stiplastics can be used for delivering single unit doses, or for doses predetermined by a laboratory. Dispensing tablets - including ones of irregular diameter - according to medical laboratory guidelines (1 by 1, 2 by 2 by 3 or 3) it can be inserted into any existing pipe, regardless of its shape. This new system also allows micro-tablets and oval capsules (such as dietary supplements) to be dispensed, a landmark in dispensing functionality. Last but not least, drugs are never trapped inside the system. Many tests have run on different sizes of pellets or micro-tablets, always with success.

The French company MEDissimo has developed the imedipac® connected pill for seven days of treatment, which includes 28 compartments. Filled by the pharmacist, the person in charge of the patient or the patient himself, each compartment contains the appropriate drug dose for a specific time of day. The user is identified by the NFC card once the imedipac® is inserted into the smart box.

The time when the pills should be taken are calculated automatically according to the pharmacological data. On opening the compartment, a light turns on and the smart box emits a sound, message or initiates a phone call to indicate to the patient it is time to take their medication. The LED remains lit for a set period.

If the time expires, the light turns off on the compartment and an alarm sounds to warn the patient. The pill is connected to a GPRS connection; a secure platform then sends the information to a smartphone, computer or tablet and a designated contact is warned that the patient has not taken his medication.

Supply chain security

Technologies developed to safe-guard products from counterfeiting are increasingly advanced to meet the regulations of the pharmaceuticals market and the expectations of pharmaceuticals companies to protect their brands and products.

 As a leader in providing vision-inspection solutions, Mettler-Toledo's latest PCE track and trace serialisation solution is a perfect example of how to combat counterfeit goods.The specialised vision inspection technology marks and tracks all units as they move through the production line, including single cartons, bottles and vials, bundles, shipping cases and palettes.  It also provides solutions to meet serialisation requirements in the pharmaceutical industry in order to combat instances of counterfeiting, ensuring full traceability and compliance with industry regulations as well as brand protection against counterfeit products.

Mr Bernard Jacob, product manager, Mettler-Toledo PCE France, explains the importance of this solution to the pharmaceuticals industry: "We can offer a high-speed solution that can print a data matrix code, verify it is correct, inspect the weight, apply a label for tamper-evident and connect to a software platform to facilitate data collection. With one machine we can combine a number of functions - one of our strengths is that we can offer complete solutions (Vision, Software and Hardware) to our clients."

Another effective method to fight counterfeiting is the use of chemical tracers. For example ValiMark™ is a luminescent chemical tracer from Tracetag, a leading provider of high security marking and tracing technology. ValiMark™ can be incorporated in a wide range of inks, surfactants or microparticles, is stable and suitable for commercial applications in a wide range of environments.

To respond to the increasing obligation for traceability in the pharmaceutical industry, ADENTS has developed its Pharma Suite solution. Its Pharma Suite solution identifies and affiliates each product in order to meet the regulatory requirements of serialisation in the Life Sciences sector. The solutions also address the increasingly important issues of parallel markets and counterfeit pharmaceutical and medical products.  ADENTS' software quickly adapts to all types of existing systems and equipment to optimise productivity and minimise costs. It is totally independent from hardware, MES and ERP suppliers.
 

Mr. Jean-Luc Lasne, international business development and alliance director, says, "ADENTS recognizes the imminent need for companies to find a global, robust and reliable solution for their serialisation and brand-protection system. Our mature Pharma Suite solution responds to all of these demands and goes further by being GAMP5 compliant and running at up to 650 boxes per minute."
 

Mr. Christophe Devins, CEO of ADENTS continues, "With only 26% of companies having started to roll-out serialisation solutions across multiple sites globally, the pharmaceutical Serialization and Traceability summit is a strategic forum for life science organizations to make important decisions to be in a position to comply with upcoming regulations. We are convinced that our Pharma Suite solution ticks all the boxes for an easily integrated and cost-effective global solution."